Manager, Regulatory Affairs
Location: Emeryville, CA
The Manager, Regulatory Affairs provides assistance with clinical trial applications, which includes investigational new drug applications and clinical trial applications, and ongoing trials and post approval activities.
The Manager supports regulatory activities and supports the study management team with authoring and reviewing all materials required in submissions.
- Serve as Regulatory lead on Study Teams
- Provide Regulatory guidance, resolve study management issues or present issues back to RA accordingly
- Review investigator packages and authorize drug shipments to clinical sites
- Independently prepare submission documents for IND submissions (cover letters, forms, IND annual reports, IB annual updates)
- Ensure the quality, accuracy and format of CTA and IND regulatory submissions and other documentation comply with applicable laws, regulations, and company standards
- Facilitate project team meetings for allocated programs
- Contribute to the development and maintenance of the Regulatory Affairs working practices and procedures
- Other duties as assigned.
- BS degree and 5+ years of experience in the pharmaceutical industry, an advanced degree will be considered in lieu of industry experience
- 5 years in regulatory affairs; international experience desirable
- Computer skills, attention to detail, and ability to multitask
- Organizational, writing, communication, and time management skills needed to manage multiple ongoing projects simultaneously
- Possesses a thorough knowledge of current Global (FDA, PMDA, EMA) regulations and guidance of requirements for investigational products, IND and CTA submission requirements
- Must be a demonstrated self-starter and team player with strong interpersonal skills. Must be a hands-on player.